SAP HANA Enterprise Cloud Good X Practice (GxP) Officer - Technology Principal Consultant Job in St. Leon-Rot, Germany

Requisition ID: 115812

Work Area: Consulting and Professional Services

Location: St. Leon-Rot

Expected Travel: 0 - 20%

Career Status: Professional

Employment Type: Regular Full Time

COMPANY DESCRIPTION

SAP’s vision is to help the world run better and improve people’s lives.

As the cloud company powered by SAP HANA®, SAP is a market leader in enterprise application software, helping companies of all sizes and industries run better. SAP empowers people and organizations to work together more efficiently and use business insight more effectively. SAP applications and services enable our customers to operate profitably, adapt continuously, and grow sustainably.

At SAP, we believe in the power of collaboration and empower our employees to perform at their best in an environment that encourages free and open expression of ideas. You’ll work alongside creative thinkers who share your interests, while turning big ideas into reality for our customers. With innovative job training, mentors to help you grow, and the flexibility to balance your work and personal life, you’ll be able to get more out of your career. It’s no wonder that some of the sharpest minds from around the world are working for a company that is consistently recognized as a global top employer.

Now it’s your turn to take the next step and help make the world Run Simple.

PURPOSE AND OBJECTIVES

As market leader in enterprise application software, SAP helps companies of all sizes and industries run better. From back office to boardroom, warehouse to storefront, desktop to mobile device – SAP empowers people and organizations to work together more efficiently and use business insight more effectively to stay ahead of the competition.

The SAP Managed Cloud Delivery (MCD) is the operations organization of the SAP HANA Enterprise Cloud (HEC) which offers and provides real-time cloud platform, infrastructure and managed services focusing on fast time-to-value at reduced cost and risk.

HEC services and related processes can be offered to life science and healthcare customers compliant to global medical product and healthcare regulations (GxP compliant).

Within our team, we practice a trust-based working model. If you need to work flexibly from another location or at another time you can do so given your manager’s agreement.

ABOUT MCD Cross Delivery & COO

Our MCD Cross Delivery & COO team is a sub-unit of the Managed Cloud Delivery operating HANA Enterprise Cloud Services (HEC) for external customers with strong individual requirements in a highly dynamic working environment. In our team you will be part of an expert group located in Germany. The team is supporting and consulting technical projects with your deep expertise and put your ideas into action with maximum impact. We aim for enabling MCD to run better in all processes end to end. These services cover dimensions of classical process improvements as well as improvements of efficiency and effectiveness for roles and organizations.

The MCD Cross Delivery & COO team has the following responsibilities:

  • Business Process Mgmt.

  • Demand Management (Tools)

  • Automation Demand planning & strategy

  • Budget planning & controlling

  • Strategic projects

  • Knowledge Management

  • Problem Management

  • Delivery Monitoring & Reporting

  • Security & Compliance

EXPECTATIONS AND TASKS

SAP HEC SPoC for GxP related topics, e.g.:

  • Manage customer / customer interest group audits and ensure implementation of agreed measures.

  • Support customers in case of health authority inspections and audits by notified bodies

  • SAP HEC representative in GxP panels and networks like LSEC, PVG, GAMP etc.

Internal QA and consultant regarding GxP topics, e.g.:

  • Internal / sub-contractor GxP compliance checks, monitoring and audits

  • GxP compliant documents and records management (HEC qualification framework and related processes like change management etc.)

  • Check/review of GxP related processes and controls (process map including the related documentation)

  • GxP trainings and awareness for GxP compliance

  • GxP competency center

EDUCATION AND QUALIFICATIONS / SKILLS AND COMPETENCIES

  • Bachelor's degree in Business Administration, Engineering or Computer or Natural Science required from an accredited university, MBA or advanced degree in related discipline preferred

  • Very high proficiency in project management, customer communications and senior level presentations is required

Required skills:

  • Strong background on 21 CFR 11 and EU GMP Guideline Annex 11, as well as related predicate rules (pharmaceuticals / medical device regulations like 21 CFR 210/211, EU GMP Guideline, 21 CFR 820, ISO 13485)

  • Practical background from 10 successful (GxP/GMP) validation and compliance projects in a leading position related to SAP applications, as well as IT infrastructure

  • Experienced in areas relevant for SAP operations such as SAP NetWeaver ABAP, JAVA, SAP Business Objects technology/platform, HANA and Sybase ASE

  • Excellent analytical skills and focus on quality

  • Fluent in German and English is a MUST, any other language is an asset

Preferred skills:

  • Expertise with cloud provider, hosting provider or managed services providers is highly valued

  • Experience in HANA or Suite on HANA applications will be of advantage

  • Expertise of working in multi-national teams

  • SAP product experience and/or min. 6 years prior relevant solutions

  • Professional experience with large, multi-national software/IT organizations

WORK EXPERIENCE

  • Minimum of five years experiences with life science industry in the area of GxP/GMP validation and compliance

  • Experience in implementation of GxP frameworks for validation/qualification, as well as related processes (change control, patch and release management, management of documents and records etc.)

  • SAP product experience and/or min. 6 years prior relevant solutions

SAP'S DIVERSITY COMMITMENT

To harness the power of innovation, SAP invests in the development of its diverse employees. We aspire to leverage the qualities and appreciate the unique competencies that each person brings to the company.

SAP is committed to the principles of Equal Employment Opportunity and to providing reasonable accommodations to applicants with physical, sensory and/or mental disabilities. If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application, please contact us at EMEA: 49 6227 7 48599 and careers@sap.com , Americas: hrdirectamericas@sap.com , APJ: hrdirectapj@sap.com . Requests for reasonable accommodation will be considered on a case-by-case basis.

Additional Locations: